FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063818 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A CLINICAL TRAIL TO STUDY THE EFFICACY OF TWO BLOCKS TRANSVERSE ABDOMINIS PLANE AND QUADRATUS LUMBORUM BLOCK IN PATIENTS UNDERGOING CESAREAN SECTION . 
Scientific Title of Study   COMPARISON OF EFFICACY OF ULTRASOUND GUIDED TRANSVERSE ABDOMINIS PLANE BLOCK VERSUS QUADRATUS LUMBORUM BLOCK ON POSTOPERATIVE PAIN IN PATIENTS UNDERGOING LSCS:A RANDOMISED CONTROL STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR T N Rakshitha 
Designation  Postgraduate Resident 
Affiliation  BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore
Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore
Bangalore
KARNATAKA
560002
India 
Phone  9886786768  
Fax    
Email  rakshithanagesh8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MADHUMALA H R  
Designation  ASSISSTANT PROFESSOR 
Affiliation  BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore
Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore
Bangalore
KARNATAKA
560002
India 
Phone  9886786768  
Fax    
Email  drmadhumala@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR T N Rakshitha 
Designation  Postgraduate Resident 
Affiliation  Department of Anesthesiology Bangalore Medical College and Research Institute 
Address  Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore
Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore
Bangalore
KARNATAKA
560002
India 
Phone  9886786768  
Fax    
Email  rakshithanagesh8@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology Bangalore Medical College and Research Institute KR Market Bangalore 560002 
 
Primary Sponsor  
Name  Bangalore medical college and research institute 
Address  Department of Anesthesiology Bangalore Medical College and Research Institute,New Thargupet,Bangalore 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr MADHUMALA H R  Bangalore medical college and research institute  Department of Anaesthesiology Bangalore medical college and research institute KR market road -560002 bangalore Karnataka
Bangalore
KARNATAKA 
9886786768

drmadhumala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore medical college and research institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.25% bupivacaine in ultrasound guided quadratus lumborum plane block.  Single shot of 20 ml of 0.25% bupivacaine will be administered under ultrasound guided quadratus lumborum plane block in patients undergoing cesarean section after one hour of spinal anaesthesia 
Intervention  0.25% bupivacaine in ultrasound guided transverse abdominis plane block  Single shot of 20 ml of 0.25% bupivacaine will be administered under ultrasound guided transverse abdominis plane block in patients undergoing cesarean section after one hour of spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1)Patients who are willing to give consent.
2)Patients of normal singleton pregnancy beyond 36 weeks gestation posted for caesarean section.
3)Patients belonging to ASA II
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The postoperative analgesic efficacy of ultrasound guided transverse abdominis plane block and quadratus lumborum block by visual analog scale (VAS).  The postoperative analgesic efficacy of ultrasound guided transverse abdominis plane block and quadratus lumborum block by visual analog scale (VAS). 
 
Secondary Outcome  
Outcome  TimePoints 
1)to calculate the opioids used by the patients postoperatively.  to calculate the total dosage of opioids used within 72 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cesarean section is the most common surgical procedure done in  obstetrics. Effective postoperative analgesia help parturient with early recovery, breastfeeding, and ambulation. Opioids are mainly used for postoperative pain management, but the limitation of opioids includes respiratory depression causing discomfort to the parturient, other insignificant side effects include itching, urinary retention, pruritis, and GI upset. The transverse abdominis plane block has a multimodal approach in post-operative pain management. In the transverse abdominis plane block, the local anesthetic solution is injected between the internal oblique and transverse abdominis muscle. Thoracolumbar nerves arise from T6- L1 spine roots and pass-through this plane and supply sensory nerves to the anterolateral abdominal wall. Quadratus lumborum is a posterior abdominal wall block that allows the spread of local anesthetic solution behind quadratus lumborum muscle and extends beyond the thoracolumbar fascia middle layer into a triangular space called the interfascial triangle. This space is near sympathetic fibers which extend to the thoracic paravertebral space. Ultrasound imaging has renewed interest in peripheral nerve blocks reducing the risk of needle contact with critical structures. In USG guided imaging, we can directly visualize the layers of muscles, the advancing needle and the injected fluid. The advantages are technical simplicity, high analgesic effectiveness, opioid sparing, long duration and minimal side effects. Ultrasound guided Transverse abdominis plane block and Ultrasound guided quadratus lumborum decrease the acute and chronic postoperative pain following cesarean section.  As there are only a few studies done on ultrasound guided transverse abdominis plane block and ultrasound quadratus  lumborum block in cesarean patients, the study is designed to assess the efficacy of ultrasound guided transverse abdominis plane block and quadratus lumborum block for postoperative analgesia following cesarean section.

 
Close